FDA committee meets on COVID-19 vaccines for young children, and White House outlines new rules for travelers to U.S.

The worldwide tally of confirmed instances of the coronavirus-borne sickness COVID-19 topped 244 million on Tuesday, as a U.S. Meals and Drug Administration advisory committee gathered to debate and vote on whether or not to advocate the BioNTech-Pfizer vaccine for kids aged 5 to 11.

The FDA will not be obliged to comply with the advice of the committee, which is made up of unbiased specialists, but it surely typically does. If the FDA offers it the nod, it’ll then be as much as the Facilities for Illness Management and Prevention to find out whether or not kids that younger ought to get the vaccine.

Final week, a evaluate panel for the FDA discovered that the advantages of the photographs outweigh the dangers. The BioNTech-Pfizer 

vaccine is at present licensed for teenagers between the ages of 12 and 15 and absolutely accepted for people 16 and older.

The FDA said Friday that the vaccine generated an efficacy price of 90.7% in opposition to symptomatic an infection in 2,268 elementary-school-age kids seven days after they acquired the second shot. The most typical uncomfortable side effects occurred after the second dose and included ache on the injection website, fatigue and headache. There have been no critical antagonistic occasions related to the vaccine, in response to the FDA. The proposed dose for 5- to 11-year-olds is 10 milligrams, in contrast with the 30-mg dose utilized in these 12 years previous and older.

Whereas kids run a decrease threat of extreme sickness or dying than older individuals, COVID-19 has killed greater than 630 individuals 18 or youthful within the U.S., in response to the CDC. Almost 6.2 million kids have been contaminated with the coronavirus, greater than 1.1 million of these within the final six weeks because the delta variant surged, according to the American Academy of Pediatrics.

The White Home explained last week how it plans to administer vaccines to that younger age group, saying it’ll use 25,000 pediatricians’ places of work, along with 100 kids’s hospitals, “tens of hundreds” of pharmacies, and a few college and group websites.

The U.S. remains to be averaging greater than 1,400 COVID-19 deaths a day, according to a New York Times tracker, though new instances are averaging fewer than 75,000 a day, or lower than half the quantity seen in early September.

However as most instances, hospitalizations and deaths are in unvaccinated individuals, specialists are nonetheless clamoring for these individuals to get their photographs. Alaska, Montana, Wyoming and Idaho are nonetheless scorching spots, whereas Vermont, New Hampshire and Colorado are averaging extra instances a day than they had been two weeks in the past.

The CDC’s vaccine tracker is displaying that 190.7 million individuals dwelling within the U.S. are absolutely vaccinated, equal to 57.4% of the general inhabitants, and beneath the 70% wanted to cease the unfold. CDC knowledge have been displaying that extra individuals are getting boosters on daily basis than getting major photographs, and the vaccination price has barely budged in weeks.

Learn: People who got J&J’s COVID-19 shot can get a booster. Which one should they get?

Youngsters below 18 and other people from dozens of nations with a scarcity of vaccines will probably be exempt from new guidelines that can require that almost all vacationers to america be vaccinated in opposition to COVID-19, the Biden administration introduced Monday, the Associated Press reported.

The federal government would require airways to gather contact data on passengers no matter whether or not they have been vaccinated to assist with contact tracing, if that turns into needed.

Learn: The success of Merck’s antiviral — and other COVID-19 pills in development — may depend on how quickly people start taking them

Starting Nov. 8, international, nonimmigrant adults touring to america will have to be absolutely vaccinated, with solely restricted exceptions, and all vacationers will have to be examined for the virus earlier than boarding a airplane to the U.S. There will probably be tightened restrictions for American and international residents who should not absolutely vaccinated.

Learn: Some 65,000 more men than women died of COVID-19 in the U.S. through August, and Black men are at higher risk than others, study finds

Russia continues to face extreme challenges in persuading its vaccine-hesitant inhabitants to get their photographs, even after it has set yet one more one-day report dying toll of 1,106 fatalities, according to the Moscow Times. Authorities in Russian-annexed Crimea said they plan to buy cellular fridges to retailer our bodies within the metropolis of Simferopol as COVID-19 deaths proceed to rise and town’s morgues are overwhelmed.

The CDC moved Ukraine to its listing of very-high-risk locations late Monday, as CNN reported. Ukraine, the second largest nation in Europe by land space, was moved up from Stage 3, or hig” threat forCOVID-19, to Stage 4, the company’s highest threat class. It’s the second week in a row that the CDC has moved just one new nation to the Stage 4 ranks. Final week, it was the city-state of Singapore.

Strict Covid-19 vaccine necessities for employees have sparked protests in Italy, regardless of help from most individuals. WSJ’s Eric Sylvers reviews from Milan, the place the brand new guidelines supply a glimpse into the hurdles the U.S. might face when implementing an identical mandate. Picture: Piero Cruciatti/AFP/Getty Photographs

In China, the northern metropolis of Lanzhou, house to 4 million individuals, has been locked all the way down to stem a stream of latest instances, AFP reported. Residents have been ordered to not go away house besides in emergencies, because the authorities search to comprise a number of dozen instances.

In Brazil, Fb

and YouTube

have faraway from their platforms a video by Brazilian President Jair Bolsonaro through which the far-right populist made a false declare that COVID-19 vaccines had been linked with growing AIDS, as Reuters reported. Final week, Brazilian senators mentioned they had been contemplating recommending that Bolsonaro be indicted on criminal charges for allegedly bungling the response to the COVID-19 pandemic and pushing the nation’s dying toll to second highest on the planet.

In medical information, Moderna

mentioned it might provide the African Union with as much as 110 million doses of its COVID-19 vaccine. The primary 15 million doses are set to be delivered earlier than the top of this 12 months, the subsequent 35 million within the first quarter of 2022, and as much as 60 million within the second quarter of subsequent 12 months. Moderna additionally mentioned it plans to open an mRNA vaccine manufacturing facility in Africa.

See: Moderna says its COVID-19 shot generates ‘robust’ response in children 6 to 11


mentioned it, too, plans to start out constructing a producing facility for its mRNA vaccines within the African Union in 2022. As soon as accomplished, the positioning is anticipated to have the capability to provide a number of hundred million doses of BioNTech vaccines, together with the power to provide the merchandise used to make 50 million COVID-19 vaccine doses a 12 months.

BioNTech mentioned it’ll initially employees and run the power however plans to finally “switch manufacturing capacities and the know-how to native companions.” 

United Parcel Service Inc.

Chief Monetary Officer Brian Newman mentioned the supply large will ship greater than 1 billion COVID-19 vaccine doses by the top of the 12 months. That makes UPS the largest deliverer of COVID-19 vaccines, Newman instructed MarketWatch in an interview.

Because the FDA nears a choice on authorizing Pfizer’s Covid-19 vaccine for kids 5-11 years previous, public-health officers and pediatricians are sharing analysis with households to guarantee hesitant dad and mom of the shot’s security. Picture: John Locher/Related Press

Newest tallies

The worldwide tally for the coronavirus-borne sickness climbed above 244.1 million on Tuesday, whereas the dying toll edged above 4.95 million, in response to data aggregated by Johns Hopkins University.

The U.S. continues to guide the world with a complete of 45.5 million instances and 737,371 deaths. 

India is second by instances after the U.S. at 34.2 million and has suffered 445,068 deaths. Brazil has the second highest dying toll at 605,804 and 21.7 million instances.

In Europe, Russia has recorded probably the most fatalities at 228,581, adopted by the U.Okay. at 139,990.

China, where the virus was first discovered late in 2019, has had 109,264 confirmed instances and 4,809 deaths, in response to its official numbers, that are extensively held to be massively underreported.

https://www.marketwatch.com/story/fda-committee-meets-on-covid-19-vaccines-for-young-children-and-white-house-outlines-new-rules-for-travelers-to-u-s-11635257702?rss=1&siteid=rss | FDA committee meets on COVID-19 vaccines for younger kids, and White Home outlines new guidelines for vacationers to U.S.


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